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CompletedNCT06496906Updated Jul 11, 2024

Clinical and Radiographic Comparison of Two Minimally Invasive Tooth Extraction Systems

An interventional study of Tooth extraction and Benex in Tooth Extraction Status Nos, sponsored by Plovdiv Medical University. Completed at 1 site in Bulgaria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-11.

Sponsored by Plovdiv Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Sep 2021, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of the study is to compare the effectiveness of the vertical extraction system Benex and Physics forceps with the conventional extraction tools (extraction forceps and elevators) in the early wound healing period after tooth extraction, as means for minimally invasive tooth extraction.

All patients aged 18 years and over who require closed tooth extraction with good oral hygiene were eligible for participation.

Participants were randomly allocated to tooth extraction with either Benex, Physics forceps or conventional extraction tools using box randomization. Patients are followed up during the recovery period to assess pain and early wound healing, while at the time of extraction, success and buccal cortical plate fracture were evaluated.

02

Conditions studied

  • Tooth Extraction Status Nos
03

In context

Lead sponsor

Plovdiv Medical University is the lead sponsor of 16 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with teeth indicated for closed extraction
  • Teeth with at least 1mm of tissue above the bone level
  • Patients without contraindications for surgical intervention (ASA 1 or 2)
  • Patients with good oral hygiene

Exclusion criteria

Exclusion Criteria:

  • Patients with severe systemic conditions or immunosuppression
  • Teeth with mobility greater than Grade 1
  • Teeth indicated for open surgical extraction
  • Patients with acute odontogenic infections
  • Drug or alcohol abuse
  • Patients with psychiatric conditions
  • Patients on anticoagulant or antiaggregant drugs refusing to undergo prior tests and preparation for tooth extraction
  • Patients on chemotherapy, radiotherapy, or oral bisphosphonate intake
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
116 participants (actual)

Study arms

  • Experimental
    Benex tooth extraction

    This is the first study group where patients undergo extractions with presumably the vertical tooth extraction system Benex.

    Procedure: Tooth extraction · Device: Benex

  • Experimental
    Physics forceps extraction

    This is the second study group where patients undergo extractions with the presumably minimally invasive Physics forceps.

    Procedure: Tooth extraction · Device: Physics Forceps

  • Active comparator
    Convetional extraction

    This is the control group where patients undergo tooth extractions with conventional extraction forceps and elevators.

    Procedure: Tooth extraction · Device: Conventional Extraction Forceps

Interventions

  • ProcedureTooth extraction

    A regular closed tooth extraction was performed with the different devices from each arm.

  • DeviceBenex

    Benex was used to perform the intervention.

  • DevicePhysics Forceps

    Physics forceps were used to perform the intervention.

  • DeviceConventional Extraction Forceps

    Conventional Extraction Forceps were used to perform the intervention.

06

What researchers measure

Primary outcomes

  1. Extraction success

    The scale suggested by Choi was used to assess each of the extraction systems. Scored from 1 to 5. Higher is better.

    Time frame: From the beginning of the extraction to the completion of the procedure

  2. Alveolar bone buccal cortical plate preservation

    The difference between the height of the alveolar bone buccal cortical plate is measured before and after the tooth extraction. Scored in milimeters missing. Lower is better.

    Time frame: From the beginning of the extraction to the completion of the procedure

  3. VAS pain score

    Patients were asked to rate their pain experience on a visual analog scale (VAS). Measured in centimeters on 10cm line. Lower is better.

    Time frame: 0, 1, 3, 7 day

  4. Early wound healing

    Landry's early wound healing index was used to evaluated the extraction healing process. Scores from 1 to 5. Higher is better.

    Time frame: 3, 7, 10 day

07

Study locations

1 site
  • Department of Oral Surgery, Faculty of Dental Medicine, Medical University - Plovdiv
    Plovdiv, Pl 4000, Bulgaria
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06496906
Lead sponsor
Plovdiv Medical University
Responsible party
Sponsor
First posted
Jul 11, 2024
Start date
Sep 1, 2021
Primary completion
Jan 1, 2023
Completion
Jan 1, 2023
Last update
Jul 11, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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